TransfusionPhase 3TRANSFUSENCT01638416

Standard Issue Transfusion Versus Fresher Red Blood Cell Use in Intensive Care- A Randomised Controlled Trial

A Phase 3 study testing Blood transfusion in people with Transfusion and Age of Blood, run by Australian and New Zealand Intensive Care Research Centre at 60 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Transfusion, Age of Blood
What is being tested?: Blood transfusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4,994 participants
Where: 60 sitesin 5 countries
Study dates: Oct 2012to Jun 2017
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients hospitalised in ICU with an anticipated ICU stay of at least 24 hours, in whom the decision has been made by medical staff to transfuse at least one RBC unit.

Who cannot join

Age younger than 18
Previous RBC transfusion during the current hospital admission (including transfusion in another hospital for transferred patients)
Diagnosis of transplantation or hematologic diseases
Pregnancy
Cardiac surgery during the present hospital admission
Expected to die imminently (<24hrs)

Show all 9Show fewer

The treating physician believes it is not in the best interest of the patient to be randomised in this trial.
Known objection to the administration of human blood products
Participation in a competing study (see below)

Trial locations and contacts

60 sites in 5 countries.

Country

City, postcode or hospital

60 sites in 5 countries

Australia42 sites

Lyell McEwin Hospital
Adelaide
Queen Elizabeth Hospital
Adelaide
Royal Adelaide Hospital
Adelaide
Albury Hospital
Albury
Bendigo Hospital
Bendigo
Logan Hospital
Brisbane
Mater Adult Hospital
Brisbane
Mater Private Hospital
Brisbane
Princess Alexandra Hospital
Brisbane
Royal Brisbane and Women's Hospital
Brisbane
Calvary Health
Canberra
Canberra Hospital
Canberra
Dandenong Hospital
Dandenong
Geelong Hospital
Geelong
Gold Coast Hospital
Gold Coast
Gosford Hospital
Gosford
Austin Hospital
Heidelberg
Royal Hobart Hospital
Hobart
The Alfred Hospital
Melbourne, Victoria, 3004
Cabrini Hospital
Melbourne
Frankston Hospital
Melbourne
Knox Private Hospital
Melbourne
Monash Medical Centre
Melbourne
Northern Hospital
Melbourne
Royal Melbourne Hospital
Melbourne
St Vincent's Hospital
Melbourne
Sunshine Hospital
Melbourne
Western Hospital
Melbourne
Calvary Mater Newcastle
Newcastle
John Hunter Hospital
Newcastle
Fiona Stanley Hospital
Perth
Royal Perth Hospital
Perth
St John of God Murdoch Hospital
Perth
Epworth Hospital
Richmond
Blacktown Hospital
Sydney
Nepean Hospital
Sydney
Prince of Wales Hospital
Sydney
Royal Prince Alfred Hospital
Sydney
St George Hospital
Sydney
St Vincent's Hospital
Sydney
Tamworth Hospital
Tamworth
Wollongong Hospital
Wollongong

Other trials in Australia

New Zealand9 sites

Auckland City Hospital CVICU
Auckland
Auckland City Hospital DCCM
Auckland
Middlemore Hospital
Auckland
North Shore Hospital
Auckland
Christchurch Hospital
Christchurch
Dunedin Hospital
Dunedin
Waikato Hospital
Hamilton
Nelson Hospital
Nelson
Wellington Hospital
Wellington

Other trials in New Zealand

Ireland6 sites

Cork University Hospital
Cork
Beaumont Hospital
Dublin
St James's Hospital
Dublin
St Vincent's University Hospital
Dublin
Galway Regional Hospital
Galway
Limerick Regional Hospital
Limerick

Other trials in Ireland

Finland2 sites

Helsinki University Hospital
Helsinki
Tampere University Hospital
Tampere

Other trials in Finland

Saudi Arabia1 site

King Abdulaziz Medical City
Riyadh

Other trials in Saudi Arabia

About this study

Official title: A Multi-centre Randomised Double Blinded Phase III Trial of the Effect of Standard Issue Red Blood Cell Blood Units on Mortality Compared to Freshest Available Red Blood Cell Units

In Australia, blood for transfusion has a "use by" date of 42 days after collection. The actual age of blood given to patients depends on what is available at the time and the rate of usage. During the last decade, it has been reported that blood transfusion in patients admitted to intensive care was associated with an independent increase of mortality. Some research suggests that transfusion of fresher blood might help patients in the intensive care unit to reach a better recovery. This project will test whether patients who receive 'fresher' blood do better than patients who receive 'standard issue' blood.

Read the detailed description

Inclusion criteria

•Patients hospitalised in ICU with an anticipated ICU stay of at least 24 hours, in whom the decision has been made by medical staff to transfuse at least one RBC unit.

Exclusion criteria

Age younger than 18
Previous RBC transfusion during the current hospital admission (including transfusion in another hospital for transferred patients)
Diagnosis of transplantation or hematologic diseases
Pregnancy
Cardiac surgery during the present hospital admission
Expected to die imminently (<24hrs)
The treating physician believes it is not in the best interest of the patient to be randomised in this trial.
Known objection to the administration of human blood products
Participation in a competing study

Primary outcome- 90 day mortality

Secondary outcomes

28 day mortality
Persistent Organ Dysfunction combined with death at 28
Days alive and free of mechanical ventilation at day 90 post randomisation
Day alive and free of renal replacement therapy at day 90 post randomisation
Blood stream infection in ICU (post randomisation) defined using the Center for Disease Control and Prevention/National Healthcare Safety Network criteria
Length of stay in ICU and in hospital post randomisation
Febrile non-haemolytic transfusion reactions
EQ-5D score at Day 90 post randomisation

Conditions: Transfusion, Age of Blood
Being tested: Blood transfusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Blood transfusionOther
Blood transfusion in ICU patients aged 18 and over.

Study groups in NCT01638416
Study group	Role	What they receive
Standard of care	Active comparator	Blood Transfusion Standard of care- oldest blood. Receives: Other: Blood transfusion
Arm B	Other	Blood Transfusion Freshest blood. Receives: Other: Blood transfusion

What is being measured

The primary outcome is the main question the study is designed to answer.

Mortality at Day 90
Mortality at Day 90
Measured: 90 Day

Secondary outcomes (8)

Mortality at Day 28
Mortality at day 28
Measured: 28 day
Persistent Organ Dysfunction Combined With Death Measured at Day 28
Persistent Organ Dysfunction combined with death measured at day 28
Measured: day 28
Days Alive and Free of Mechanical Ventilation
Days alive and free of mechanical ventilation
Measured: day 28
Day Alive and Free of Renal Replacement Therapy.
Day alive and free of renal replacement therapy.
Measured: day 28
Blood Stream Infection in ICU (Post Randomisation)
Blood stream infection in ICU (post randomisation) Time Frame is in Days
Measured: While in ICU-Median duration in ICU - short term storage group was 4.2 days (2.0 - 9.3), long term storage group was 4.2 days (1.9 - 9.4)
Length of Stay in ICU and in Hospital Post Randomisation (Days)
Median duration in ICU - short term storage group was 4.2 (2.0 - 9.3), long term storage group was 4.2 (1.9 - 9.4) Median duration in Hospital - short term storage group was 14.5 (7.4 - 27.5), long term storage group was 14.7 (7.4 - 28.3) In Days
Measured: Median duration in ICU- short term storage group 4.2 Days (2.0 - 9.3), long term storage group 4.2 Days (1.9 - 9.4). Median duration in Hospital- short term storage group was 14.5 days (7.4 - 27.5), long term storage group was 14.7 days(7.4 - 28.3)
Proportion of Patients Who Suffer at Least One Febrile Non-haemolytic Transfusion Reaction in ICU
Proportion of patients who suffer at least one febrile non-haemolytic transfusion reaction in ICU
Measured: While in ICU-Median duration in ICU - short term storage group was 4.2 days (2.0 - 9.3), long term storage group was 4.2 days (1.9 - 9.4)
EuroQol-5Dimension 5 Level (EQ-5D-5L) Score at Day 180 Post Randomisation
EuroQol-5Dimension 5 level (EQ-5D-5L) score at day 180 post randomisation - not reported yet
Measured: Day 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2012Jun 2017

First posted11 Jul 2012 (estimated)
Study startOct 2012
Primary completionApr 2017
Study completionJun 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for TransfusionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 4,994 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01638416
Sponsor's protocol ID: ANZICRCDJC006
Acronym: TRANSFUSE
Status last verified: Oct 2020
First submitted: 9 Jul 2012
Last updated: 22 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Undecided

Publications

Radford M, Estcourt LJ, Sirotich E, Pitre T, Britto J, Watson M, Brunskill SJ, Fergusson DA, Doree C, Arnold DM. Restrictive versus liberal red blood cell transfusion strategies for people with haematological malignancies treated with intensive chemotherapy or radiotherapy, or both, with or without haematopoietic stem cell support. Cochrane Database Syst Rev. 2024 May 23;5(5):CD011305. doi: 10.1002/14651858.CD011305.pub3.
PubMed 38780066
Cooper DJ, McQuilten ZK, Nichol A, Ady B, Aubron C, Bailey M, Bellomo R, Gantner D, Irving DO, Kaukonen KM, McArthur C, Murray L, Pettila V, French C; TRANSFUSE Investigators and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Age of Red Cells for Transfusion and Outcomes in Critically Ill Adults. N Engl J Med. 2017 Nov 9;377(19):1858-1867. doi: 10.1056/NEJMoa1707572. Epub 2017 Sep 27.
PubMed 28952891
Kaukonen KM, Bailey M, Ady B, Aubron C, French C, Gantner D, Irving D, Murray L, Nichol A, Pettila V, McQuilten Z, Cooper DJ. A randomised controlled trial of standard transfusion versus fresher red blood cell use in intensive care (TRANSFUSE): protocol and statistical analysis plan. Crit Care Resusc. 2014 Dec;16(4):255-61.
PubMed 25437218
Kekre N, Mallick R, Allan D, Tinmouth A, Tay J. The impact of prolonged storage of red blood cells on cancer survival. PLoS One. 2013 Jul 16;8(7):e68820. doi: 10.1371/journal.pone.0068820. Print 2013.
PubMed 23874777

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Evaluation the Safety and Efficacy of KL003 Cell Injection in the Treatment of Transfusion-dependent β-thalassemia.
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All Transfusion trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-centre Randomised Double Blinded Phase III Trial of the Effect of Standard Issue Red Blood Cell Blood Units on Mortality Compared to Freshest Available Red Blood Cell Units
ClinicalTrials.gov ID: NCT01638416
Acronym / sponsor ID: TRANSFUSE / ANZICRCDJC006
Conditions: Transfusion, Age of Blood
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 4,994 participants (actual)
Lead sponsor: Australian and New Zealand Intensive Care Research CentreUniversity, hospital or other
Collaborators: Australian Red Cross, New Zealand Blood Service, Irish Blood Transfusion Service, Finnish Red Cross Blood Service, King Abdulaziz Medical City, University College Dublin
Study start: Oct 2012
Primary completion: Apr 2017 (actual)
Study completion: Jun 2017 (actual)
First posted: 11 Jul 2012 (estimated)
Results: Posted 22 Oct 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Inclusion criteria

•Patients hospitalised in ICU with an anticipated ICU stay of at least 24 hours, in whom the decision has been made by medical staff to transfuse at least one RBC unit.

Exclusion criteria

Age younger than 18
Previous RBC transfusion during the current hospital admission (including transfusion in another hospital for transferred patients)
Diagnosis of transplantation or hematologic diseases
Pregnancy
Cardiac surgery during the present hospital admission
Expected to die imminently (<24hrs)
The treating physician believes it is not in the best interest of the patient to be randomised in this trial.
Known objection to the administration of human blood products
Participation in a competing study

Primary outcome- 90 day mortality

Secondary outcomes

28 day mortality
Persistent Organ Dysfunction combined with death at 28
Days alive and free of mechanical ventilation at day 90 post randomisation
Day alive and free of renal replacement therapy at day 90 post randomisation
Blood stream infection in ICU (post randomisation) defined using the Center for Disease Control and Prevention/National Healthcare Safety Network criteria
Length of stay in ICU and in hospital post randomisation
Febrile non-haemolytic transfusion reactions
EQ-5D score at Day 90 post randomisation

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Standard of care	Active comparator	Other: Blood transfusionBlood Transfusion Standard of care- oldest blood.
Arm B	Other	Other: Blood transfusionBlood Transfusion Freshest blood.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients hospitalised in ICU with an anticipated ICU stay of at least 24 hours, in whom the decision has been made by medical staff to transfuse at least one RBC unit.

Key exclusion criteria (9 listed)

Age younger than 18
Previous RBC transfusion during the current hospital admission (including transfusion in another hospital for transferred patients)
Diagnosis of transplantation or hematologic diseases
Pregnancy
Cardiac surgery during the present hospital admission

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Blood transfusionBlood transfusion in ICU patients aged 18 and over.	Other	Arm B, Standard of care

Primary outcome

Mortality at Day 90
Time frame: 90 Day
Mortality at Day 90

8 secondary outcomes

Mortality at Day 28
Time frame: 28 day
Persistent Organ Dysfunction Combined With Death Measured at Day 28
Time frame: day 28
Days Alive and Free of Mechanical Ventilation
Time frame: day 28
Day Alive and Free of Renal Replacement Therapy.
Time frame: day 28
Blood Stream Infection in ICU (Post Randomisation)
Time frame: While in ICU-Median duration in ICU - short term storage group was 4.2 days (2.0 - 9.3), long term storage group was 4.2 days (1.9 - 9.4)
Length of Stay in ICU and in Hospital Post Randomisation (Days)
Time frame: Median duration in ICU- short term storage group 4.2 Days (2.0 - 9.3), long term storage group 4.2 Days (1.9 - 9.4). Median duration in Hospital- short term storage group was 14.5 days (7.4 - 27.5), long term storage group was 14.7 days(7.4 - 28.3)
Proportion of Patients Who Suffer at Least One Febrile Non-haemolytic Transfusion Reaction in ICU
Time frame: While in ICU-Median duration in ICU - short term storage group was 4.2 days (2.0 - 9.3), long term storage group was 4.2 days (1.9 - 9.4)
EuroQol-5Dimension 5 Level (EQ-5D-5L) Score at Day 180 Post Randomisation
Time frame: Day 180

Results and safety

Results posted to the registry on 22 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm B (Short Term Storage)	2,490	2,457
Standard of Care (Long-term Storage)	2,504	2,462

Primary outcome: Mortality at Day 90

Time frame: 90 Day. Number. Unit: participants

Measure	Arm B (Short Term Storage) n = 2457	Standard of Care (Long Term Storage) n = 2462
All patients	610	594
Group O	264	259
Non-Group O	346	335
APACHE III risk of Death <21.5%	152	169
APACHE III risk of Death =or>21.5%	457	425
Baseline SOFA score = or < 7	210	191
Baseline SOFA score >7	400	403

Population analysed: Pre specified Sub groups

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Primary outcome was all-cause mortality measured up to day 90. Secondary outcomes included mortality / persistent organ dysfunction or death / days alive and free of mechanical ventilation / days alive and free of renal-replacement therapy measured all measured at day 28, new bloodstream infection measured during ICU stay, febrile nonhemolytic transfusion reactions during ICU stay, length of stay (hospital and ICU), and quality of life measured at day 180 after randomization.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm B (Short Term Storage)	0 of 2,457 (0%)	158 of 2,457 (6.4%)	687 of 2,410
Standard of Care (Long Term Storage)	0 of 2,462 (0%)	127 of 2,462 (5.2%)	678 of 2,414

Limitations and caveats (from the sponsor): The red-cell age in each treatment group was not prespecified but was determined by the blood-bank inventory at each institution. We did not design the trial to assign red cells toward the end of their shelf life (35 to 42 days).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38780066Radford M, Estcourt LJ, Sirotich E, Pitre T, Britto J, Watson M, Brunskill SJ, Fergusson DA, Doree C, Arnold DM. Restrictive versus liberal red blood cell transfusion strategies for people with haematological malignancies treated with intensive chemotherapy or radiotherapy, or both, with or without haematopoietic stem cell support. Cochrane Database Syst Rev. 2024 May 23;5(5):CD011305. doi: 10.1002/14651858.CD011305.pub3.
Derived from this study: PubMed 28952891Cooper DJ, McQuilten ZK, Nichol A, Ady B, Aubron C, Bailey M, Bellomo R, Gantner D, Irving DO, Kaukonen KM, McArthur C, Murray L, Pettila V, French C; TRANSFUSE Investigators and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Age of Red Cells for Transfusion and Outcomes in Critically Ill Adults. N Engl J Med. 2017 Nov 9;377(19):1858-1867. doi: 10.1056/NEJMoa1707572. Epub 2017 Sep 27.
Derived from this study: PubMed 25437218Kaukonen KM, Bailey M, Ady B, Aubron C, French C, Gantner D, Irving D, Murray L, Nichol A, Pettila V, McQuilten Z, Cooper DJ. A randomised controlled trial of standard transfusion versus fresher red blood cell use in intensive care (TRANSFUSE): protocol and statistical analysis plan. Crit Care Resusc. 2014 Dec;16(4):255-61.
Derived from this study: PubMed 23874777Kekre N, Mallick R, Allan D, Tinmouth A, Tay J. The impact of prolonged storage of red blood cells on cancer survival. PLoS One. 2013 Jul 16;8(7):e68820. doi: 10.1371/journal.pone.0068820. Print 2013.
Individual participant dataSharing planned: Undecided

Related trials for Transfusion

Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
RecruitingPhase 3
A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions
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RecruitingPhase 3
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Active, not recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

D. James Cooper, A.O., M.D. principal investigator

Monash University/Alfred Hospital

60 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Blood transfusion in people with Transfusion and Age of Blood, run by Australian and New Zealand Intensive Care Research Centre at 60 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in Australia, New Zealand, Ireland, Finland, Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality at Day 90 (time frame: 90 Day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01638416, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.